10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MICROMAX SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
Leksell Stereotactic System
FDA UDI
Elekta Solutions AB·07340201503003·X-RAY INDICATOR WITH MARKERS - POSTERIOR
Tiche PTA Balloon Dilatation Catheter
FDA UDI
BrosMed Medical Co.,Ltd.·06958481476132·
DS2ADV AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 31, 2025
D/C CORE MATERIAL
FDA 510(k)
FDA Class 2
·Dental
BRACHYSEED
FDA 510(k)
FDA Class 2
·Radiology
STELLARIS 25GA POSTERIOR PACK W AFI & WF
FDA Adverse Event
Malfunction
·BAUSCH & LOMB, INC.·Product code HQC·April 3, 2013
LIBERTY DRAIN LINE, LUER TAPER CONNECTOR
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE, REYNOSA MANUFACTURING·Product code KDJ·August 15, 2014
UNK DEPUY DURALOC 1200 SERIES 62MM CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWB·May 8, 2008
Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016